Actions

Full Text of this Amendment

SA 1047. Mr. ROBERTS (for himself, Mr. Harkin, Mr. Burr, and Mr. Coburn) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

Strike subparagraphs (E) and (F) of section 505(o)(5) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and insert the following:
``(E) SPECIFIC DISCLOSURES.--
``(i) SERIOUS RISK; SAFETY PROTOCOL.--If the Secretary determines that advertisements lacking a specific disclosure about a serious risk listed in the labeling of a drug or about a protocol to ensure safe use described in the labeling of the drug would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure.
``(ii) DATE OF APPROVAL.--If the Secretary determines that advertisements lacking a specific disclosure of the date a drug was approved and disclosure of a serious risk would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure.
``(iii) SPECIFICATION OF ADVERTISEMENTS.--The Secretary may specify the advertisements required to include a specific disclosure under clause (i) or (ii).
``(iv) REQUIRED SAFETY SURVEILLANCE.--If the approved risk evaluation and mitigation strategy for a drug requires the specific disclosure under clause (ii), the Secretary shall--
``(I) consider identifying and assessing all serious risks of using the drug to be a priority safety question under subsection (k)(3)(B);
``(II) not less frequently than every 3 months, evaluate the reports under subsection (k)(1) and the routine active surveillance as available under subsection (k)(3) with respect to such priority drug safety question to determine whether serious risks that might occur among patients expected to be treated with the drug have been adequately identified and assessed;
``(III) remove such specific disclosure requirement as an element of such strategy if such serious risks have been adequately identified and assessed; and
``(IV) consider whether a specific disclosure under clause (i) should be required.
On page 101, strike lines 7 through 9.
At the end of the bill, add the following:
SEC. __. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.
(a) Civil Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:
``(g)(1) Any applicant (as such term is used in section 505(o)) who disseminates a direct-to-consumer advertisement for a prescription drug that is false or misleading and a violation of section 502(n) shall be liable to the United States for a civil penalty in an amount not to exceed $150,000 for the first such violation in any 3-year period, and not to exceed $300,000 for each subsequent violation committed after the applicant has been penalized under this paragraph any time in the preceding
3-year period. For the purposes of this paragraph, repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered as 1 violation.
``(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the applicant to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If upon receipt of the written notice, the applicant to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary
may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3).
``(3) Upon the request of the applicant to be assessed a civil penalty, the Secretary, in determining the amount of a civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors:
``(A) Whether the applicant submitted the advertisement or a similar advertisement for review under section 736A.
``(B) Whether the applicant submitted the advertisement for prereview if required under section 505(o)(5)(D).
``(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the applicant disseminated the advertisement before the end of the 45-day comment period.
``(D) Whether the applicant failed to incorporate any comments made by the Secretary with regard to the advertisement or a similar advertisement into the advertisement prior to its dissemination.
``(E) Whether the applicant ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement.
``(F) Whether the applicant had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination.
``(G) Whether the violations were material.
``(H) Whether the applicant who created the advertisement acted in good faith.
``(I) Whether the applicant who created the advertisement has been assessed a civil penalty under this provision within the previous 1-year period.
``(J) The scope and extent of any voluntary, subsequent remedial action by the applicant.
``(K) Such other matters, as justice may require.
``(4)(A) Subject to subparagraph (B), no applicant shall be required to pay a civil penalty under paragraph (1) if the applicant submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary.
``(B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the applicant of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1).
``(5) The Secretary may compromise, modify, remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owned by the United States to the applicant charged.
``(6) Any applicant who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such applicant resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order
making such assessments was issued.
``(7) If any applicant fails to pay an assessment of a civil penalty--
``(A) after the order making the assessment becomes final, and if such applicant does not file a petition for judicial review of the order in accordance with paragraph (6); or
``(B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.''.
(b) Direct-to-Consumer Advertisement.--
(1) IN GENERAL.--Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting after the first sentence the following: ``In the case of an advertisement for a prescription drug presented directly to consumers in television or radio format that states the name of the drug and its conditions of use, the major statement relating to side effects, contraindications, and effectiveness referred to in the previous sentence shall be stated in a clear and
conspicuous (neutral) manner.''.
(2) REGULATIONS TO DETERMINE NEUTRAL MANNER.--The Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement, relating to side effects, contraindications, and effectiveness of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph (1)) is presented in the manner required under such section.

(As printed in the Congressional Record for the Senate on May 7, 2007.)